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Abstract

Introduction: Previous studies in patients with type 2 diabetes (T2DM) have shown an association between retinopathy (RET) and neuropathy (NEUR) and cardiovascular (CV) outcomes, although this relationship is less clear in those with prior CV events.

Hypothesis: RET and NEUR augment risk for subsequent CV events in people with T2DM and recent acute coronary syndrome (ACS).

Methods: ELIXA (NCT01147250, sponsored by Sanofi) enrolled 6068 patients (mean age 60±10; 69% men) with T2DM and recent ACS. Data on RET and NEUR history were self-reported at screening. Proportional hazards regression models were used to assess the association between RET and NEUR and CV events.

Results: At screening, RET and NEUR were reported in 10.7% and 16.7% of patients, respectively, and both in 5.5%. Patients who had RET and/or NEUR were older, had longer duration of T2DM, higher fasting glucose, HbA1c, and urine albumin to creatinine ratio, lower eGFR, and more frequently used insulin in comparison to those without RET or NEUR. In multivariate analysis, the most important predictor of either RET or NEUR was duration of T2DM. There was an association of RET and/or NEUR with primary endpoint composite (CV death, nonfatal myocardial infarction/stroke, hospitalization for unstable angina) (RET: HR=1.34 (1.09-1.65); NEUR: HR=1.20 (1.00-1.44)) and HF hospitalization (RET: HR=1.74 (1.24-2.45); NEUR: HR=1.44 (1.06-1.96)). RET, but not NEUR remained significant after adjustment for demographic and CV risk factors. However, all associations became nonsignificant after adjusting for duration of T2DM.

Conclusions: RET and NEUR are predictive of subsequent CV events in patients with T2DM and recent ACS. However, both of these associations can be accounted for by duration of T2DM.